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SO YOUNG GLOBAL

⚠️ Moderate Risk

FEI: 3014080086 • Tsim Sha Tsui Center • HONG KONG

FEI

FEI Number

3014080086

📍

Location

Tsim Sha Tsui Center

🇭🇰

Country

HONG KONG
🏢

Address

Room 602a, 6/F, West Wing, Tsim Sha Tsui Center, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
3
Unique Violations
2/14/2018
Latest Refusal
2/14/2018
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
2/14/2018
64EAY05COLLAGENASE (ENZYME)
335LACKS N/C
473LABELING
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SO YOUNG GLOBAL's FDA import refusal history?

SO YOUNG GLOBAL (FEI: 3014080086) has 1 FDA import refusal record(s) in our database, spanning from 2/14/2018 to 2/14/2018.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. SO YOUNG GLOBAL's FEI number is 3014080086.

What types of violations has SO YOUNG GLOBAL received?

SO YOUNG GLOBAL has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about SO YOUNG GLOBAL come from?

All FDA import refusal data for SO YOUNG GLOBAL is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.